NCT02377258

Brief Summary

The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients. We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

March 4, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

6.2 years

First QC Date

February 26, 2015

Last Update Submit

August 2, 2022

Conditions

IBD

Keywords

Lymphomasafetybiologic therapies

Outcome Measures

Primary Outcomes (1)

  • assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

    assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

    3 years

Secondary Outcomes (4)

  • Disease modification

    3 Years

  • ePRO

    3 Years

  • Benefit-Risk

    3 Years

  • Cost Efficacy

    3 Years

Study Arms (6)

1

without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)

Other: Non Interventional

2

with on-going anti-TNF monotherapy

Other: Non Interventional

3

with thiopurines monotherapy

Other: Non Interventional

4

with on-going combination therapy

Other: Non Interventional

5

patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)

Other: Non Interventional

6

patients on ustekinumab (alone or on combination therapy)

Other: Non Interventional

Interventions

Non InterventionalOTHER
123456

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)

You may qualify if:

  • CD or UC
  • Capable to complete eDiary on a regular basis, and have access to smartphone or internet
  • Accepted to participate and provide personal information (name, phone and email) for contact
  • Accepted to be contacted by study coordinators on a regular basis for follow up with missing information

You may not qualify if:

  • Unable to sign consent
  • Unable to access internet or use smartphone
  • Refused to sign consent or to provide personal identification information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (2)

  • Peyrin-Biroulet L, Nazar M, Sheahan A, Geldhof A, Azzabi A, Baert F, Mailhat C, Rousseau H, Rahier JF, Beaugerie L. Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data. Dig Liver Dis. 2026 Jan;58(1):74-81. doi: 10.1016/j.dld.2025.09.026. Epub 2025 Oct 25.

    PMID: 41139534DERIVED

  • Peyrin-Biroulet L, Rahier JF, Kirchgesner J, Abitbol V, Shaji S, Armuzzi A, Karmiris K, Gisbert JP, Bossuyt P, Helwig U, Burisch J, Yanai H, Doherty GA, Magro F, Molnar T, Lowenberg M, Halfvarson J, Zagorowicz E, Rousseau H, Baumann C, Baert F, Beaugerie L; I-CARE Collaborator Group. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2023 Mar;21(3):771-788.e10. doi: 10.1016/j.cgh.2022.09.018. Epub 2022 Sep 22.

    PMID: 36152897DERIVED

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Laurent Peyrin-Biroulet, MD, PhD

    Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 3, 2015

Study Start

March 4, 2016

Primary Completion

May 16, 2022

Study Completion

May 16, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

FR(1)